U.S. patent number 5,713,876 [Application Number 08/483,949] was granted by the patent office on 1998-02-03 for catheter release mechanism.
This patent grant is currently assigned to Johnson & Johnson Medical, Inc.. Invention is credited to David L. Bogert, Thomas K. Sutton.
United States Patent |
5,713,876 |
Bogert , et al. |
February 3, 1998 |
Catheter release mechanism
Abstract
A catheter insertion device incorporating a simple lever and
clip structure which will safely lock a catheter hub of a catheter
assembly to a normally disposable cannula housing and guard
structure and which, in a simple mode, enables separation of the
catheter hub from the cannula assembly or structure upon retraction
and protective guarding of the used cannula. Specifically, an
aspect resides in providing the lever release clip for a safety
catheter which upon unlocking and releasing of the catheter hub
concurrently pushes the catheter hub off a nose guard of the
cannula assembly, while enabling a physician or clinical personnel
to release the catheter by employing only one hand. A further
embodiment is adapted to enable separation between the catheter hub
of a flexible catheter and the needle or cannula arrangement of a
catheter insertion device by simply manipulating a lever arranged
on a cannula structure or nose guard thereof by simply pushing
against a push-tab element.
Inventors: |
Bogert; David L. (Plainville,
CT), Sutton; Thomas K. (Carrollton, TX) |
Assignee: |
Johnson & Johnson Medical,
Inc. (Arlington, TX)
|
Family
ID: |
23922146 |
Appl.
No.: |
08/483,949 |
Filed: |
June 7, 1995 |
Current U.S.
Class: |
604/243;
604/187 |
Current CPC
Class: |
A61M
25/0631 (20130101); A61M 2005/3109 (20130101); A61M
25/0111 (20130101); A61M 2005/3206 (20130101) |
Current International
Class: |
A61M
25/06 (20060101); A61M 5/32 (20060101); A61M
5/31 (20060101); A61M 25/01 (20060101); A61M
005/00 () |
Field of
Search: |
;604/243,264,187,164-170,240,241,242 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Yasko; John D.
Attorney, Agent or Firm: Shirtz; Joseph F.
Claims
What is claimed is:
1. A catheter insertion device, comprising;
(a) a housing for receiving a cannular needle, said cannular needle
extending from an end of said housing and being adapted to
administer a catheter to a patient;
(b) a needle nose guard slidably mounted on said housing, said
cannular needle extending through said nose guard in the operative
position of said cannular needle;
(c) a catheter hub supporting structure being provided on said
needle nose guard;
(d) a catheter slidably mounted on said cannular needle, said
catheter including a catheter hub engaged on said catheter hub
supporting structure; and
(e) a lever-clip means being arranged on said catheter hub
supporting means, said lever-clip means being actuatable in at
least one direction to facilitate locking of said catheter hub to
said catheter hub supporting structure in the extended operative
position of said cannular needle and being actuatable in at least
one other direction subsequent to retraction of said cannular
needle into a protective environment so as to release and push said
catheter hub off said catheter hub supporting structure.
2. A catheter insertion device as claimed in claim 1, wherein said
lever-clip means comprises a plate-shaped element mounted on said
catheter hub supporting means.
3. A catheter insertion device as claimed in claim 2, wherein said
plate-shaped element comprises a projecting tab member actuatable
in response to pressure being exerted thereagainst by a finger of a
user of said device.
4. A catheter insertion device as claimed in claim 3, wherein said
housing includes at least one gripping surface engageable by the
hand of the user possessing the finger for actuating said
lever-clip means.
5. A catheter insertion device as claimed in claim 1, wherein said
lever-clip means is molded from a resiliently deformable plastic
material.
6. A catheter insertion device as claimed in claim 1, wherein said
lever-clip means is integrally formed with said needle nose
guard.
7. A catheter insertion device as claimed in claim 1, wherein said
lever-clip means comprises a push-tab on said needle nose
guard.
8. A catheter insertion device as claimed in claim 7, wherein said
push-tab is integrally formed with said needle nose guard.
9. A catheter insertion device as claimed in claim 1, wherein said
lever-clip means comprises a hub portion mountable on said needle
nose guard, and lever means hingedly connected with said hub
portion adapted to be resiliently deflected for pushing said
catheter hub off the catheter hub supporting structure.
10. A catheter insertion device as claimed in claim 9, wherein said
hub portion and lever means of said lever-clip means comprises a
unitarily formed structure.
11. A catheter insertion device as claimed in claim 10, wherein
said unitarily formed structure is constituted from a molded
plastic material.
12. A catheter insertion device as claimed in claim 1, wherein said
needle nose guard includes means for retracting said cannular
needle into said protective environment.
13. A catheter insertion device as claimed in claim 1, wherein
audible indication is provided relative to the positions of said
cannular needle in said device.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates, in general, to intravenous catheter
insertion devices, and in particular relates to a catheter
insertion device incorporating a simple lever and clip structure
which will safely lock a catheter hub of a catheter assembly to a
normally disposable cannula housing and guard structure and which,
in a simple mode, enables separation of the catheter hub from the
cannula assembly or structure upon retraction and protective
guarding of the used cannula. Specifically, an aspect of the
invention resides in providing the lever release clip for a safety
catheter which upon unlocking and releasing of the catheter hub
concurrently pushes the catheter hub off a nose guard of the
cannula assembly, while enabling a physician or clinical personnel
to release the catheter by employing only one hand. The invention
is further adapted to enable separation between the catheter hub of
a flexible catheter and the needle or cannula arrangement of a
catheter insertion device by simply manipulating a lever arranged
on a cannula structure or nose guard thereof by simply pushing
against a push-tab element.
The utilization of clinical apparatus in which pointed hollow
needles or cannulas are employed in order to puncture the skin of a
patient, and especially catheters utilizing such needles to
effectuate venipunctures, is well known in the medical art and is
widely practiced by physicians and clinical personnel for the
purpose of injecting fluids and drugs directly into the bloodstream
of patients. Additionally, during surgical operations or procedures
it may be frequently required that whole blood transfusions and
parenteral fluids be administered to a patient undergoing such
surgical procedures. Basically, as is well known and has been
employed for a considerable length of time, the introduction of
such fluids into the cardiovascular systems of patients has
necessitated the forming of a venipuncture utilizing a hollow rigid
needle having a proximal attachment site for a fluid connection
which is adapted to interconnect the needle with a source of
intravenously administered fluids.
The foregoing method of administering fluids to patients through
venipuncture has been subject to some rather serious problems in
the administration of fluids to patients in this medical
technology. Thus, a primary concern which had to be addressed
resided in the inherent rigidity of the needle, the latter of which
is normally constituted of surgical-quality steel, and while
inserted into the vein of a patient necessitated the needle to be
maintained for reasons of safety in a fixed position at the general
site of the venipuncture throughout the duration of fluid
administration or transfusion, whereby such a procedure could
conceivably consume a considerable length of time. In addition to
the foregoing, at times it has been necessary to periodically draw
blood samples and/or successively administer intravenous fluids to
a patient, thus requiring the patient to be subjected to a series
or plurality of venipuncture, each administered at a specific time
and at different sites on the body, resulting in a relatively
traumatic experience for patients in view of such repeated and
somewhat painful and unpleasant venipunctures.
In order to ameliorate or possibly even eliminate the foregoing
problems in the medical technology, it has been more recently the
practice to introduce a flexible tubular catheter of a low-friction
material, such as a silastic or Teflon into the vein of a patient
and to permit the catheter tube to remain in such a position over
lengthier periods of time for purposes of; for example,
periodically administering fluids, including parenteral fluids,
blood/plasma transfusions, medications in liquid form and also for
the collection of blood samples and the like. In this manner, the
previously encountered trauma, extravasation, and infiltration
caused by repeated venipuncture have been largely avoided, and the
danger and discomfort to a patient of leaving a rigid needle in the
body for a prolonged period of time has been generally overcome.
Thus, in order to position the distal end of such a flexible
catheter tube within the body cavity of a patient, such as a
vascular cavity or vein, there is normally employed a cannula or
hollow sharp-tipped needle for the purpose of forming the
venipuncture. Thereafter, the flexible catheter tube, which is
telescopically and slidably coaxially mounted on the outer
circumference of the cannula or hollow needle so as to extend
sleeve-like thereabout is advanced along the length of the needle
into the vein subsequent to the needle having formed the
venipuncture. Thereafter, the needle is adapted to be withdrawn
from the interior of the catheter tube, while permitting the latter
to remain within the body of the patient at the site of the
venipuncture, and the needle is suitably discarded.
Inasmuch as the needle which has been previously positioned in the
body of the patient upon forming the venipuncture may have been
exposed to infectious agents; for instance, such as a patient
infected with the Acquired Immune Deficiency Syndrome (AIDS) which
is frequently or practically always ultimately fatal in nature, or
other dangerous infectious conditions such as hepatitis, there is
present the danger or hazard that the clinical personnel may
inadvertently or accidentally jab or stick themselves with the used
needle after withdrawal from the body of the patient, with the
possibility of infection or even death resulting therefrom.
Heretofore, in order to release the structure which contains the
used retracted needle or cannula from a lock on a catheter hub, the
latter of which remains attached to a flexible catheter tube
extending into the site of the puncture in the patient's body, it
was frequently necessary for the clinician or physician to employ
both hands in order to implement the separating operation between
the catheter hub and used cannula structure so as to enable the
subsequent attachment of a complementary Luer lock fitting to the
Luer lock lug on the catheter hub for enabling the introduction of
quantities of a parenteral fluid, supply of blood/plasma, or other
medications to the patient in an intravenous procedure. Frequently,
this necessitated that the clinical personnel was required to carry
out, almost simultaneously or in rapid succession, two or three
procedural steps, rendering the steps difficult to implement
without the use of both hands, and possibly, upon occasion, even
necessitating that one of the steps be delayed pending the
completion of preceding steps in the separating of the catheter and
cannula components.
2. Discussion of the Prior Art
Thus, U.S. Pat. No. 4,762,516 to Luther et al. discloses the
retraction of a used needle or cannula into a protective housing.
However, this necessitates the further procedure of having to
release a catheter while essentially employing two hands.
Although other publications disclose various structures and methods
for releasing catheters and their catheter hub structures from
cannula assemblies while the cannulas have been retracted into a
clinical personnel-protective environment, none disclose the
employment of simple operative structure, such as a lever-clip
device, which will enable locking of the catheter to the cannula
assembly and also facilitate pushing the cannula hub off the
housing or nose/guard components for the cannula when the latter is
in its retracted position.
SUMMARY OF THE INVENTION
Accordingly, in order to facilitate a one-handed separation and
relative manipulation of the catheter and cannula components of the
intravenous catheter insertion device; especially the detachment
from the catheter of the structure and elements containing the used
cannula or hollow needle which was previously employed in forming
the venipuncture, while permitting the catheter and thereto
attached catheter hub, the latter of which comprise a part of a
Luer lock lug or fitting, to remain in position at the site of the
venipuncture, pursuant to the invention there is utilized a novel
lever and clip arrangement which is positioned intermediate a
housing for the containment of the cannula or needle, and including
a nose guard projecting into the catheter hub, through the
implementation of a simple one-handed manipulation of the lever and
clip arrangement. This, in essence, renders simple the process of
separating the catheter and cannula housing components by enabling
a user to grip the housing structure containing the retracted used
cannula and with one or more fingers of the same hand to manipulate
the lever and clip so as to effectuate the release and pushing off
of the catheter hub in a single motion.
Accordingly, it is an object of the present invention to provide a
novel lever and clip arrangement enabling the separation of a
safety catheter hub from a disposable cannula assembly.
Another object of the present invention is to provide a simple
lever and clip structure mountable on the components of the
intravenous catheter insertion device comprising a catheter hub of
a safety catheter assembly and housing a nose guard structure
adapted to receive a needle or cannula for forming the venipuncture
in a patient, and whereby upon a simple manipulation of a clip or
lever on the device which is operable with one hand of a user
holding the device, it is possible to separate the components
thereof to enable removal of the cannula and related components in
a protective state while permitting the therefrom released and
pushed-off catheter hub and thereto attached catheter extending
into the venipuncture in the patient's body to remain in place.
BRIEF DESCRIPTION OF THE DRAWINGS
The foregoing and other objects and advantages of the invention may
now be more readily ascertained from the following detailed
description of various embodiments of the inventive device, taken
in conjunction with the accompanying drawings; in which:
FIG. 1 illustrates an intravenous catheter injection device
incorporating a lever and release clip structure pursuant to the
invention;
FIG. 2 illustrates the device of FIG. 1 in the process of being
locked into operative position;
FIG. 3 illustrates the device of FIG. 1 in the process of the
catheter hub being released from the cannula structure upon
retraction of the cannula;
FIGS. 4a through 4f illustrate various successive steps in
respectively the operation and assembly of the lever and release
clip structure pursuant to the inventive device;
FIG. 5 illustrates a rear view of the lever and release clip;
FIG. 6 illustrates a front view of the lever and release clip;
FIG. 7 illustrates a side view of the lever and release clip;
FIG. 8 illustrates a sectional view taken along Line 8--8 in FIG.
5;
FIGS. 9 and 10 illustrate a catheter insertion arrangement in,
respectively, operative and cannula-retracted positions
thereof;
FIG. 11 illustrates a modified version of a lever and release clip
structure on a catheter insertion device;
FIG. 12 illustrates the catheter insertion device of FIG. 11 in the
process of being locked;
FIG. 13 illustrates the device of FIG. 11 in the process of being
unlocked so as to separate the catheter hub from a nose guard
portion of the device;
FIGS. 14a through 14c illustrate sequential steps in the assembly
of the lever and release clip of FIG. 11;
FIGS. 15, 16 and 17 illustrate, respectively, front, side and
sectional views of the lever and release clip utilized in the
embodiment of FIG. 11, FIG. 17 being a sectional view taken along
Line 17--17 in FIG. 15;
FIGS. 18 and 19 illustrate perspective views of another version of
a catheter insertion device pursuant to the invention in,
respectively, operative and cannula-retracted positions
thereof;
FIG. 20 illustrates another embodiment of a catheter insertion
device utilizing a lever and clip structure;
FIGS. 21 and 22 illustrate the device of FIG. 20 in, respectively,
catheter locking and unlocking modes;
FIG. 23 illustrates a front view of the combined lever and clip and
cannula guard structure utilized in the catheter device embodiment
of FIG. 20;
FIG. 24 illustrates a sectional view taken along Line 24--24 in
FIG. 23;
FIG. 25 illustrates a further modified catheter insertion device
pursuant to the invention; and
FIGS. 26 and 27 illustrate the catheter device of FIG. 25 in,
respectively, the catheter locking and unlocking modes thereof.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
Referring in more specific detail to FIG. 1 of the drawings, there
is illustrated an intravenous catheter insertion device 10
incorporating a catheter (not shown) having a cannular needle 12
projecting therefrom, wherein the needle is generally of surgical
steel construction adapted to be inserted into the vein of a
patient in the shown extended position thereof. The insertion
device 10 includes a guard 14 and a housing 16, and wherein the
structure thereof includes a nose section 18 comprising a snap-in
nose 20. A lever and release clip 22 is mounted at the leading end
of the guard 14 and, as shown in FIG. 2 of the drawings, the hub 26
of the catheter is adapted to be attached to the housing 16 in a
locked position. In order to ensure that the locking position has
been ascertained, an audible "click" may be generated upon locking.
At this point the catheter hub 26 is locked in place, with the
extended cannula 12 passing therethrough in extended position ready
for venipuncture, and the catheter hub will not separate from the
cannula assembly without any deliberate actions being imparted
thereto by a physician or clinician. This, in essence, imparts a
degree of a "fail-safe" operation to the catheter insertion
device.
Upon the cannula 12 having been fully retracted into the protective
housing 16, in order to separate the catheter and its catheter hub
26 from the remaining insertion structure, so as to remain in the
vein of the patient, as is illustrated in FIG. 3 of the drawings, a
user would push back and then down on the lever clip 22 with one
finger, releasing the catheter hub 26 and concurrently pushing the
latter off the nose guard and housing. It is also possible for the
user of the catheter insertion device 10 to merely push off and
release the catheter hub 26 by pushing forward somewhat harder on
the clip tab 30 and, in the event the user is implementing a
difficult catheter insertion into a patient, it is possible for him
or her to release the catheter hub 26 prior to locking so as to
impart a more sensitive "feel" to the insertion of the cannula 12
into the vein of the patient.
Referring to FIGS. 4a through 4c, there are shown successive steps
in the assembly of the lever and release clip 22 of FIG. 1.
As shown in FIG. 4a, the lever-clip 22 is snapped onto the nose
guard piece 18; and in FIG. 4b the properly oriented catheter hub
26 is then snapped onto the lever-clip and nose guard assembly.
FIG. 4c illustrates the entire arrangement in the assembled and
operatively locked condition thereof.
In order to release the catheter and its catheter hub 26 from the
remaining cannula structure, as discussed with regard to FIG. 3 of
the drawings, FIG. 4d illustrates the nose guard 18 being locked
over the cannula point, with the cannula 12 or hollow needle (not
shown) being in the fully retracted or guarded position within the
housing structure 16.
Thereafter, as shown in FIG. 4e of the drawings, the user or
clinical personnel pushes downwardly on the lever clip 22 in the
direction of arrow A, thereby both releasing and pushing off the
catheter hub 26 as shown in the directions of arrows B.
Thereafter, with the catheter hub 26 and the attached catheter tube
remaining in place, the latter having its leading or free end
inserted into the vein of the patient, the cannula assembly
comprising the nose guard 18, the housing 16 and lever clip 22 is
removed and discarded.
As shown in FIGS. 5 through 8, the lever release clip 22 is
constituted from a molded plastic material, preferably of a
relatively soft plastic, such as polyethylene, having the nose
guard formed thereon, in order to prevent any damage to the
catheter hub Luer lock lugs during assembly therewith. This
catheter insertion device 10, in essence, both releases and pushes
off the catheter hub 26 when finger pressure is applied to the top
of the lever clip 22, although the device is also capable of
facilitating somewhat modified methods of catheter release; for
instance, such as by pushing against and deflecting of the lever
clip.
Referring to FIGS. 9 and 10, there are shown perspective views of a
catheter insertion device 40, in which, as shown in FIG. 9, the
cannula 42 projects from a nose guard 44 of a unitary structure,
and extends from a housing 46, as known per se.
upon a lever clip 48 which is mounted on the nose guard 44 being
tilted, as shown by arrow A in FIG. 10, the catheter hub (not
shown) can be separated from the cannula assembly by simply pulling
back on the lever clip or tab 44 of the nose guard. This tab
portion 44 of the nose guard can be molded with an integral hinge
to facilitate this type of function.
Referring to the catheter insertion device 50 in the embodiment of
FIG. 11, in this instance there is also illustrated a modified
version of a lever clip 56 wherein the catheter hub 52 is
introduced into the lever clip opening and over the nose guard
portion 54 as in the embodiment of FIG. 1 of the drawings.
As shown in FIG. 12, this locking action is effected by pushing the
lever clip 56 somewhat forwardly, generating an audible "click" to
provide indication of such locking action having been
implemented.
Conversely, in order to release the catheter hub 52 with the
catheter tube from the cannula structure subsequent to locking, a
user would simply pull back and/or down on the lever clip 56 as
shown in the direction of arrow A in FIG. 13, thereby pushing the
catheter hub off the nose. Other lever motions can of course also
be contemplated herein.
As shown in FIG. 14a through 14c, there are disclosed the
successive steps in the assembly of the lever clip 56 of the device
50 of FIG. 11.
In FIG. 14a the lever clip 56 is oriented and snapped onto a rib
formed on the nose guard portion 54 of the cannula structure. An
unoriented catheter hub 52 is then pressed into place on the nose
guard, as shown in FIG. 14b; and thereafter as shown in FIG. 14c,
the entire catheter arrangement is in an assembled and operatively
locked condition.
Illustrated in FIGS. 15 through 17 of the drawings is the
configuration of the lever clip 56 showing the latter to be an
essentially plate like structure having a central aperture 60
whereby, upon pulling back and/or pushing down on the lever-like
structure of the lever clip, the catheter hub 52 is either pushed
off or released from the nose guard portion 54 of the catheter
insertion device 50. This particular lever clip structure does not
require that the Luer lock lugs on the catheter hub 52 be oriented
inasmuch as it pushes on the body of the hub and not on the lugs
which are employed for forming a Luer lock connection subsequent to
the withdrawal and detachment of the cannula structure. Inasmuch as
this construction does not hold or release the Luer lock lugs on
the catheter hub, any method which is currently employed for the
release of the catheter can be utilized in addition to the
above-described "one-finger" technique as shown in FIGS. 12 and 13
of the drawings.
Referring to the embodiment of FIGS. 18 and 19, illustrating in
perspective view two positions of a catheter insertion device 70,
whereby in FIG. 18 the cannula 72 is shown extended from the nose
guard 74 and, in FIG. 19, is protectively retracted therein and
into housing 76. This structure permits a user to utilize the same
"one-handed" catheter separation techniques as previously
mentioned, with the so-called push-tab/guard 78 being unlocked only
when the nose guard 74 is locked thereby permitting pushing off of
the catheter hub by exerting continuing finger pressure on the push
tab 78.
As illustrated in FIG. 20 of the drawings, this is a somewhat
modified version 80 of the previous devices with the exception
being that the lever-clip arrangement 82 is integrally formed with
the nose and guard structure 84.
Hereby, the operation of locking the catheter hub 86 to the cannula
structure as in FIG. 21 is identical to that as described with
regard to FIG. 1, with an audible "click" noise signifying that a
locking action has taken place.
Conversely, as shown in FIG. 22, after locking of the catheter hub
86, the latter can be disengaged by any method currently employed
as hereinbefore described. In addition, a user can pull back
slightly on the push-tab 88 on the nose guard so as to disengage
the catheter hub 86 from the cannula structure; in effect,
providing for a "one-handed" operation.
As shown in FIGS. 23 and 24, the guard and snap-in nose portion 82
having the projecting lever 82 thereon are integrally molded, using
a living hinge 90 to enable the lever portion, as shown in FIGS. 21
and 22, to be resiliently tilted in opposite directions so as to
cause the contacting lower projecting end portion 92 thereof to be
able to push the catheter hub 86 away from and off the remaining
cannula structure, as shown in FIG. 22 of the drawings.
Similarly, as shown in FIGS. 25 through 27, the lever and structure
100 of this catheter device 102 is a simple one-piece or unitarily
molded nose guard 104 having a protruding member 106 in the form of
a tiltable lever whereby, as shown in FIG. 26, the forward movement
thereof enables the catheter hub 108 to be locked into position
onto the nose portion 110 of the cannula assembly 112, and with the
extension of the telescoping arrangement 114, 116 for receiving the
retracted cannula to be smooth and chatter-free in operation
through the employment of a suitable lubricous plastic
material.
The unlocking action for separating the catheter hub 108 and its
attached catheter tube from the remaining cannula structure,
whereby the cannula has been retracted into its protective
position, can be implemented in a manner as described hereinbefore
by simply pulling back upon the tiltable lever 106 as shown in FIG.
27. The user may also pull back slightly on the push tab 120 on the
nose guard 104 to disengage the catheter hub 108 from the
disposable cannula structure pursuant to the inventive "one-handed"
operation of the device.
While there has been shown and described what are considered to be
preferred embodiments of the invention, it will, of course, be
understood that various modifications and changes in form or detail
could readily be made without departing from the spirit of the
invention. It is, therefore, intended that the invention be not
limited to the exact form and detail herein shown and described,
nor to anything less than the whole of the invention herein
disclosed as hereinafter claimed.
* * * * *